China NMPA Product Recall - X-ray imaging system

Shimadzu International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific X-ray imaging systems, a measure reported to the National Medical Products Administration (NMPA) on August 11, 2017. The recall was prompted by the discovery of potential cracks in a very small number of these devices, identified by Registration No. 20053311268(Revised). While the exact inspection dates are not provided, the company proactively reported the issue and commenced the recall process. This action aligns with the NMPA's regulatory framework, which mandates manufacturers to address product quality concerns and ensure medical device safety. The required action involved the voluntary removal of the affected X-ray imaging systems from the market to mitigate any potential risks. Detailed information regarding the models, specifications, and batch numbers of the affected products is available in the associated "Medical Device Recall Event Report Form."